Purpose

This study is designed to compare the anti-tumor activity as well as the safety and efficacy
of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer
subjects previously treated with trastuzumab and taxane.

Inclusion Criteria

has confirmed HER2-positive expression as determined according to American
Society of Clinical Oncology - College of American Pathologists guidelines
evaluated at a central laboratory

was previously treated with trastuzumab and taxane in the advanced/metastatic
setting or progressed within 6 months after neoadjuvant or adjuvant treatment
involving a regimen including trastuzumab and taxane

Has documented radiologic progression (during or after most recent treatment or within
6 months after completing adjuvant therapy)

Is HER2 positive as confirmed by central laboratory assessment of most recent tumor
tissue sample available. If archived tissue is not available, agrees to provide a
fresh biopsy.

If of reproductive/childbearing potential, agrees to use a highly effective form of
contraception or avoid intercourse during and upon completion of the study for at
least 4.5 months after the last dose of DS-8201a or 7 months after the last dose of
T-DM1

Has adequate renal and hepatic function

Exclusion Criteria

Has previously been treated with an anti-HER2 antibody drug conjugate (ADC)

Has uncontrolled or significant cardiovascular disease

Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at screening

Has spinal cord compression or clinically active central nervous system (CNS)
metastases, defined as untreated and symptomatic, or requiring therapy with
corticosteroids or anticonvulsants to control associated symptoms.

Participants with clinically inactive brain metastases may be included in the
study.

Participants with treated brain metastases that are no longer symptomatic and who
require no treatment with corticosteroids or anticonvulsants may be included in
the study if they have recovered from the acute toxic effect of radiotherapy. A
minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy
and study enrollment.

More Details

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

This study (NCT03529110) was last processed and updated on 6/3/2020 by ClinicalTrials.gov.